Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.

Severe Brain Injury Clinical Trial

Official title:

Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426242
• Other study ID #: RC13_0354
• Status: Completed
• Phase: N/A
• First received: April 21, 2015
• Last updated: September 12, 2016
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.

To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring = 48 hours of mechanical ventilation after admission

Exclusion Criteria:

• Pregnant women

• Patient consent withdrawal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Severe Brain Injury

Intervention

Other:
• Collection of medical data from ICU patients
A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation failure	Extubation failure is regarded as the need of intubation in the 48 hours following extubation Establish clinial signs before extubation that can predict extubation failure Realization of a systematic clinical examination by the attending physician before performing extubation in severe brain-injured patients	In the 48 hours following extubation	No
Secondary	Impact of extubation failure	Impact of extubation failure on; Duration of mechanical ventilation; Length of ICU stay; Mortality Describing reasons	Median 14 days after Intensive Care Unit (ICU) admission	No